Using a FOCUS-PDCA quality improvement model for applying the severe traumatic brain injury guidelines to practice: process
and outcomes

Trauma teams strive to provide care based on best practice. Exploring the clinical outcomes of patients sustaining severe
traumatic brain injury (TBI) at our trauma centre from 1994–97 we found that the outcomes were marginal at best: 43% of our
patients expired and 30% suffered severe disability. These results were consistent with those of some studies on TBI published
in the 1980s. Researchers in the past decade have used new technology for monitoring the effects of secondary brain injury
and examined the effects of various treatment modalities on the outcomes of patients with TBI. In 1995, the American Association
of Neurological Surgeons (AANS) evidence-based clinical guidelines for managing severe TBI were published.1 The guidelines recommended changes in the care of patients with TBI and challenged caregivers to evaluate their practices
and examine the clinical outcomes of this high risk group.

Motivated by the new practice recommendations and the potential for greatly affecting patient outcomes, Mission Hospital Regional
Medical Center’s (MHRMC) multidisciplinary neurotrauma team convened in 1997 to begin performance improvement. Current practice
was examined and new hospital based clinical guidelines were developed. Numerous changes were recommended as the team dismantled
current practice patterns and constructed new care priorities. The result was a series of algorithms with established outcomes
at every phase of the patient’s hospital course. Four years after integrating the changes in practice, the team evaluated
prospectively collected data to determine outcomes for patients with severe TBI. Current outcomes (2001 data) indicated that
72.8% of patients had a good outcome (no disability to moderate disability), 13.6% had severe disability to persistent vegetative
state, and 13.6% died. We will present a FOCUS-PDCA performance improvement approach to show the processes used to apply national
scientific guidelines to the clinical setting. Statistical analysis using an ordinal regression model will show outcome data
emphasising the positive aspects of applying evidence-based guidelines to practice.

Summary of FOCUS-PDCA

FOCUS is an acronym for the words find, organise, clarify, understand, and select. PDCA is an acronym for plan, do, act, and
check results.

FIND A PROCESS TO IMPROVE

The trauma/neurosurgical physician and nursing leaders at MHRMC gathered in 1997 to facilitate the transition of research
based scientific guidelines to clinical practice. The guidelines for managing severe head injury developed by the AANS challenged
physicians and other health team members to examine current practice regarding severe TBI patients and to alter care practices,
which had been viewed as the “gold standard” of care for years. Analysis of the TBI guidelines and related literature indicated
recommendations to avoid hypoxia and hypotension; maintain a mean arterial pressure <90 mm Hg and cerebral perfusion pressure
>70 mm Hg using fluids and vasopressors; treat intracranial pressure (ICP) >20 mm Hg; avoid hyperventilation to control ICP
unless cerebral oxygenation measured; give boluses of mannitol intermittently and replace fluids to maintain euvolemia; use
barbiturates for uncontrollable ICP; decrease stimulation in the environment; treat fever aggressively; use sedation or analgesia
in continuous modes; and incorporate clinical pathways and algorithms concerning planned therapy including weaning procedures.1

ORGANISE TO IMPROVE THE PROCESS

The team leaders began by examining the current care processes for the population with TBI at MHRMC. They conducted a review
of the literature and contacted a manufacturer of cerebral oxygenation (SjO2) catheters concerning product availability. A decision was made by the leaders to form a multidisciplinary team to examine
current practice, analyse the published TBI guidelines and research, and develop new treatment plans.

CLARIFY THE ISSUE

The neuro clinical nurse specialist (CNS) conducted a retrospective chart review of the previous 3.5 years. Patients included
in the study were those with a closed head injury and (a) Glasgow Coma Score (GCS) from 3–8, (b) abnormal computed tomography
(CT) scan of the brain, (c) age >8 years, and (d) ICP monitoring. Excluded from the study results were patients with penetrating
head injury; patients who died or were pronounced brain dead within 24 hours of admission; patients with a GCS 3–8 because
of alcohol, seizures, or systemic injury; and patients with absence of head injury as determined by CT or clinical exam. In
all, 1 937 trauma records were reviewed (January 1994 to June 1997). Almost half of the patients had sustained some form of
head injury but only 37 met inclusion criteria. Results of the outcome study were that 27% had an outcome of zero to moderate
disability; 30% had severe disability or persistent vegetative state (PVS); and 43% died.

After the chart audit, a multidisciplinary task force was established consisting of trauma surgeons, neurosurgeons, anaesthesiologists,
intensivists, rehabilitation personnel, critical care nurses, respiratory therapists, and pharmacists. Before the meeting,
all members received a copy of the TBI guidelines and supporting research articles. The neuro CNS facilitated 2 meetings to
compare the guidelines to current practice and establish clinical guidelines for use at the hospital.

UNDERSTAND THE SOURCES OF VARIATION AND SELECT THE PROCESS TO IMPROVE

The team discovered that current practice deviated from the published guidelines in several areas including blood pressure
(BP) and fluid management; use of hyperventilation to treat increased ICP; use of medications to decrease cerebral oxygen
demand, enhance BP, and decrease ICP; temperature management; and use of technology such as SjO2 catheters to monitor cerebral oxygenation. Recommendations from members of the team were to discontinue the old treatment
processes and implement a new care process incorporating the AANS TBI guidelines and recommendations in the literature that
were focused on decreasing ICP, maximising BP, and optimising cerebral oxygenation. The team integrated information on manipulation
of cerebral oxygenation so as to maintain normal oxygen levels.2

PLAN, DO, AND ACT—JUNE 1997

Changes were recommended as the team changed practice patterns and implemented new care priorities. Every aspect of caring
for patients with severe TBI from admission in the emergency department (ED), through the operative and intensive care unit
(ICU) phase, to rehabilitation was examined. The result was to develop a series of algorithms with established outcomes at
every phase of a patient’s hospital course. Input from every member of the multidisciplinary team was sought for the care
process. SjO2 catheters were stocked in the hospital, a procedure was developed, and the staff was educated. The team developed a TBI documentation
form, algorithms for the ICU team, and clinical guidelines addressing the needs of adults and children. In addition, staff
members in the paediatric and adult ICUs, ED, and operating room (OR) were educated about the new process. The first patient
to be cared for using the new guidelines was admitted in June 1997. This change in practice required close supervision and
clinical support of team members by the neuro CNS who provided clinical support for all shifts.

CHECK RESULTS—JUNE 1998

Analysis of care processes, data, and outcomes was integral to maintain consistency of care and coordination of services.
Data were collected prospectively by the neuro CNS. Analysing outcomes for 18 patients using the new guidelines indicated
that 61% had a good outcome with zero to moderate disability; 11% had severe disability or PVS; and 27% died. Feedback from
members of the team included several concerns regarding the management of these patients.

Team members were concerned about variations in intubation procedures; variation in maintaining minimum BP levels for the
ED and OR phases of care; variation in timing the placement of SjO2 catheters; variations in intra-operative management; and instances of increased incidence of pneumonia, poor renal perfusion,
nutritional problems, and acute withdrawal symptoms because of sudden removal of analgesics.

ACT—AUGUST 1998

The neuro CNS reconvened the multidisciplinary team and reviewed the results of the first year. The key issues identified
above were divided into phases of care and changes in practice were recommended. New clinical algorithms were developed. The
team developed (a) protocols for rapid sequence intubations, narcotic withdrawal, and vasopressor support; (b) goals such
as BP, ICP, and cerebral oxygenation levels for each phase of care; (c) nutritional management goals, with emphasis on post-pyloric
feedings, which would provide nutrition into the small intestine instead of into the stomach; (d) interventions for aggressive
pulmonary management; and (e) ways to use nursing research about management of environmental stimulation and family presence.
We implemented changes in practice after approval by committees and staff education.

CHECK AGAIN—FEBRUARY 2000

Outcome data were evaluated once again. 56 patients were cared for since the change in practice in June 1997 and dramatic
improvement in outcomes was noted: 69% had a good outcome of zero to moderate disability, 14% had severe disability or PVS,
and 16% died. We sought the assistance of an independent statistician to analyse the data. Patients in Group 1 (n=37) were
those treated before the TBI guidelines were implemented and patients in Group 2 (n=56) were those treated after TBI guidelines
were implemented. A comparison of descriptive statistics using a student t test revealed no significant difference between the 2 groups concerning the variables of age, injury severity score, GCS
on admission, number of days receiving ICP monitoring, number of days on mechanical ventilation, ICU length of stay (LOS),
and hospital LOS. Statistically significant differences were noted between the 2 groups concerning hospital charges ($197
128 average for patients in Group 1 and $293 065 average for patients in Group 2). Using an ordinal regression model, the
odds for significant variables were examined and adjusted for the effect of all other variables in the model. Results of the
ordinal regression model were (a) patients in Group 2 had odds of a good outcome relative to odds of a poor outcome or death
9 times higher compared with patients in Group 1 (p=0.005); (b) patients with a GCS >8 at the time of admission had odds of
a good outcome 6.58 times higher compared with the patients admitted with a GCS <8 (p=0.003); and (c) odds of a good outcome
decreased by a factor of 0.92 for each 1 year increase in patients’ age starting at age 9 (p=0.0005).

Team members believe the change in outcomes of the severe TBI population was because of an aggressive standardised approach
to managing multiple parameters and to the integration of advanced technology related to brain oxygenation. By integrating
team interventions into one protocol, nurses, physicians, respiratory therapists, and members of other disciplines coordinated
their interventions and understood the effect on patients. Using a standardised approach has been reported to be successful
in other centres.3–5

ACT AGAIN—2000

The team recognised the need to encourage more family involvement in the care of patients with severe TBI. The TBI Task Force
2000 met and included hospital staff from all units, 4 former patients, and several family members. Using a qualitative approach,
input from all members was gathered and 4 teams established new care practices involving: (a) patients emerging from coma;
(b) structure of the physical environment in all units; (c) consistency and continuity of care; and (d) patient and family
education and support.

Families are educated about the ICU environment and encouraged to be present at their ICU patient’s bedside as much as possible.
Therapeutic touch by family members is encouraged and supported. Members of the nursing and rehabilitation teams from units
where the patient will be cared for meet the family while the patient is in the ICU. Families receive relevant education as
patients move through each phase of care. Care practices and outcomes are continually monitored.

Data collected about patients (n=81) at the end of fiscal year 2000 showed that 72.8% had good outcomes of zero to moderate
disability, 13.6% had severe disability or PVS, and 13.6% died. These outcomes indicated to the team that the changes in practice
and intense cooperation resulted in a difference in their patients. Each team member’s collaboration and respect for others
were evident in actions and words. This multidisciplinary team evolved and became synergistic with each patient and family.
This synergy has enabled us to affect outcomes of severely brain injured patients at MHRMC.